ORTHOCORD
Suture, Surgical, Absorbable, Polydioxanone
DEPUY MITEK INC., A JOHNSON AND JOHNSON COMPANY
The following data is part of a premarket notification filed by Depuy Mitek Inc., A Johnson And Johnson Company with the FDA for Orthocord.
Pre-market Notification Details
| Device ID | K123668 |
| 510k Number | K123668 |
| Device Name: | ORTHOCORD |
| Classification | Suture, Surgical, Absorbable, Polydioxanone |
| Applicant | DEPUY MITEK INC., A JOHNSON AND JOHNSON COMPANY 325 Paramount Drive Raynham, MA 02767 |
| Contact | Tatyana Korsunsky |
| Correspondent | Tatyana Korsunsky DEPUY MITEK INC., A JOHNSON AND JOHNSON COMPANY 325 Paramount Drive Raynham, MA 02767 |
| Product Code | NEW |
| CFR Regulation Number | 878.4840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-29 |
| Decision Date | 2013-02-26 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20886705022967 | K123668 | 000 |
| 20886705022950 | K123668 | 000 |
| 20886705022943 | K123668 | 000 |
| 20886705022936 | K123668 | 000 |
| 20886705022929 | K123668 | 000 |
| 20886705022912 | K123668 | 000 |
| 20886705022905 | K123668 | 000 |
Trademark Results [ORTHOCORD]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ORTHOCORD 78382222 3340861 Live/Registered |
Johnson & Johnson 2004-03-11 |
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